FDA.report

OSSEOSTAP Control Unit

Primary DI
17630055505641
Brand
OSSEOSTAP Control Unit
Company
Bien-Air Surgery SA
Model
1600686
Catalog number
1600686-001
Published
2023-02-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

Product Code Classifications

CodeDeviceSpecialtyClass
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
J00716006860011PreviousHIBCC0
17630055505641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1763005550564117630055505641

GMDN Terms

TermDefinition
Surgical power tool system control unit, line-poweredA mains electricity (AC-powered) component of a line-powered surgical/dental power tool system intended to step down the electrical power from the mains to supply the handpiece/motor (not included), and may also be intended to regulate some of the functions of the connected power tools (e.g., speed and torque); it may be intended for single or multiple clinical applications (i.e., dedicated or non-dedicated). This device may have integrated irrigation functionality and may be operated through hand and/or foot controls.

Sterilization Methods

Method

Regulatory Flags

DUNS number
481597719
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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17630055519624Bur PM2-70 80K diamC Ø2.5x80 St11014252026-02-16
17630055519631Bur PM2-70 80K diamC Ø3.0x80 St11014172026-02-16
17630055519648Bur PM2-70 80K diamC Ø3.5x80 St11014262026-02-16
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17630055519686Bur PM2-70 80K steel Ø3x80 St11013992026-02-16
17630055519693Bur PM2-70 80K diamC Ø2.5 St11013822026-02-16
17630055519709Bur PM2-70 80K diamC Ø4.0x80 St11014272026-02-16

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